The applicants of the present application, J I Xunming et al., filed applications entitled Cerebrovascular and Cardiovascular Health Care and Therapeutic Equipment in 2007 (with the application numbers of 200720173945.9 and 200710176701.0). In 2011, the applicant, upon applying for a category classification for such equipment before China Food and Drug Administration, named the equipment for said purpose as “ischemic precondition training treatment equipment”, and the name was adopted by China Food and Drug Administration. Subsequently, products of this category are all entitled “ischemic precondition training treatment equipment” for application, registration or commercial purpose. Nevertheless, after long-term clinical application and patient tracking service, some problems still exist in the known ischemic precondition training. These problems are not totally solved by the prior patent documents and products, which are illustrated as follows:
CN202335859U discloses a remote ischemic preconditioning equipment, which adopts the technical solution of adding a device to the main body of electronic sphygmomanometer, in which the device could inflate and deflate the armlet multiple times in a repeated, continuous and timing way, so as to repeatedly and continually block the blood flow of the limbs in short time. CN 202505429U is realized by adding a sensing means for measuring the oxygen value of pulse on the basis of the equipment disclosed in CN202335859U, in which the equipment is continuously pressurized 200 mmHg until the oxygen value of pulse cannot be measured, then the inflating pump ceased to work, and the pressure value is that set for blocking blood flow. Since the oxygen value of pulse refers to the oxygen content measured according to the oxygen content in blood per every pulse in vessel, the value measured in accordance with said method, in practical use, is admitted under the circumstances that the arm is under normal condition, i.e. the arm is not pressed and the blood vessel is not blocked. When the armlet begins to inflate, it presses the arm and the blood is blocked, and thus the oxygen value of pulse rapidly decreases to zero. Under such condition, the pressure value in armlet is not certain. Even another 200 mgHg pressure is added to the uncertain pressure value (as basis), the pressure required for preconditioning training is still not satisfied, which would incur swelling pain in practice.
Patent documents CN203263775U and CN203315307U disclose that “by adopting said structure, the present utility model is concluded through multiple repeated experiments to have the advantages of promoting the patients' blood circulation by pressing repeatedly to relax the upper and lower limbs, in such a way to produce stress reaction as a result of the blocked limbs being ischemic stimulated instantly”. Such design cannot satisfy the requirements for preconditioning training method, i.e. the requirements for blocking vessels of upper limbs rapidly. The reason is that, during the process of inflating and applying pressure to the airbag of the upper limbs in the preconditioning training, the pressure applied to arms would firstly block the superficial veins, i.e. blocking bloods to reflow to heart, while the deep arterial vessels are not blocked and would still deliver bloods to arms; if larger pressure cannot be applied rapidly, fingers would swell and extravasate, and thus the treatment equipment cannot be extruded repeatedly. As to the training on lower limbs by means of the airbag described in the patents, it can be clearly determined from the existing documents that the preconditioning training cannot be practiced on lower limbs, since such action would make thrombosis in lower limb venography to be an event of larger probability.
CN202801711U discloses a remote ischemic preconditioning training equipment, which comprises a first pressure sensor in the air pressure regulation portion for providing a real-time feedback of air pressure, and a second pressure sensor disposed in the contact part between the armlet and the user for measuring the real-time pressure of the armlet on user's arm. Said equipment is to train users by applying dynamic extrusion to user's arms. Such design is not directed to the key points of ischemic preconditioning training method, and may make the preconditioning treatment uncomfortable or potentially risky.
The applicants ZHENG Cai'er et al. and the associated enterprise successively applied a plurality of patents (CN203138608U, CN203139071U, CN102895013A and CN203169547U) for ischemic preconditioning treatment equipment. The patent documents describe that “Capital Medical University-Xuanwu Hospital adopts an in vitro safe physical non-invasive method, i.e. a distal ischemic precondition training method”, for being used in ischemic precondition training. Moreover, the patents mentioned that “there is no study on medical apparatuses and equipment using said principle in the present industry, and how to fully utilize the principle to study the corresponding medical apparatus and equipment is a topic faced by those skilled in the art”. In fact, Capital Medical University-Xuanwu Hospital, as the national pioneer search team in ischemic preconditioning training, has successively developed the preconditioning treatment equipment in the year of 2008. Moreover, the developed equipment is further studied and improved these years and has served thousands of patients. Nevertheless, the ischemic preconditioning treatment equipment in aforementioned patents have disadvantages in clinical application and structure, rendering the patients having discomfortableness of swelling and extravasated blood in fingers during preconditioning training owing to the unreasonable design regarding the internal gas way structure. Additionally, as to the equipment of said patent documents, there are imperfections in disposition of inflator pumps and patient experience, and no adjustments are made regarding the key points of the ischemic preconditioning training method. Thus, the equipment disclosed in said patent documents are merely for realizing the function of ischemic preconditioning treatment, but the ischemic preconditioning treatment object cannot be really achieved.
In conclusion, the existing distal ischemic preconditioning treatment equipment are mostly obtained through improvement on the known sphygmomanometer. It is true that the provided technical solutions could substantially accomplish said function according to the requirements for ischemic preconditioning training; however, the treatment effect of ischemic preconditioning treatment can be accomplished with the proviso that the patients insist on using it for at least three months, and the prevention object can only be achieved only if the users keep on training for a long term. Moreover, some equipment are modified to restrict the power of gas pump for achieving the accuracy of blood pressure measurement. Although such modified structures could make the equipment achieve preconditioning training function, they cannot accomplish effective preconditioning training, and further cannot produce excellent treatment effect.
At present, the diagnosis standard for inter-arm blood pressure difference (IAD) is that: if IAD≥10 mmHg, it will be deemed as abnormity. Some studies classify the systolic pressure IAD (sIAD) into two grades: the first grade of sIAD≥10 mmHg, and the second grade of sIAD≥20 mmHg. Moreover, the diastolic pressure IAD (dIAD) is ≥10 mmHg. If a patient has high IAD, it is reminded that the patient might have peripheral vascular disease.
The current research findings show that in 386 patients suspected to have coronary heart disease, 27 patients (7%) with sIAD ≥15 mmHg have larger myocardial ischemia area, 63% of the IAD patients are diagnosed to have coronary heart disease and 83% of them suffer from multivessel disease. Thus, IAD may be an indication for coronary artery lesions.
Currently, most foreign scholars use the name of inter-arm blood pressure difference (IAD). Now, it is generally deemed that the IAD of systolic pressure and diastolic pressure for normal people shall both be lower than 10 mmHg. There are two relevant studies in foreign countries at present. In one study, 83 patients were observed and followed-up for 5.6 year, which shows that the mean event-free survival of dIAD is 3.3 year, and that of non-dIAD is 5.0 years (P<0.0001). In the other study, 421 patients were observed and followed-up for 7 years. These two studies show that the cardio-cerebrovascular disease event in IAD patients increases. Having corrected the factors of mean systolic pressure and chronic nephrosis, it is found that for every 10 mmHg sIAD variation, the mortality risk ratio is 1.24 (95% credibility interval is 1.01-1.52). A prospective study in the United States shows that if the blood pressure disparity of two arms of a patient is ≥20/10 mmHg, the incidence and mortality of cardio-cerebrovascular disease would increase significantly.
Clark C E et al. published a paper in the famous medical journal Lancet, which, by analyzing the previous medical documents, determines that the risk of having cardio-cerebrovascular disease may be to some extend predicted according to the blood pressure disparity between two arms. Relevant study reports include 28 papers. According to the reports, there is evidence showing that if IAD reaches 10 mmHg, the patient may suffer from peripheral vascular disease; if the IAD is higher than 15 mmHg, the risk of having peripheral vascular disease (i.e. the vascular narrows and hardens) is high, and it may also shows that the person suffers from a pre-existing cerebrovascular disease. The reason is that the high IAD renders the risk of reduction in blood that flows to two legs and two feet being increased by 2.5-fold, the risk of reduction in blood that flows to the brain being increased by 1.6-fold, the risk of dying from cardiovascular disease being increased by 70%, and the risk of dying from other diseases being increased by 60%. If the health condition can be judged according to the measured IAD numerical value and the peripheral vascular disease (PVD) can be discovered earlier, the measures of reducing blood pressure and cholesterol and quitting smoking are helpful for reducing the risk of death.